Black Cohosh and the Symptoms of Menopause

This fact sheet provides an overview of the use of black cohosh for menopausal symptoms.

Key points

  • Black cohosh is an herb sold as a dietary supplement in the United States.
  • Black cohosh is used for hot flashes and other menopausal symptoms.
  • Although preliminary evidence is encouraging, the currently available data are not sufficient to support a recommendation on the use of black cohosh for menopausal symptoms.
  • In 2001, the American College of Obstetricians and Gynaecologists stated-primarily on the basis of consensus and expert opinion-that black cohosh may be helpful in the short term (6 months or less) for women with vasomotor symptoms of menopause.
  • Although few adverse events have been reported, long-term safety data are not available.

What is black cohosh?

Black cohosh (known as both Actaea racemosa and Cimicifuga racemosa), a member of the buttercup family, is a perennial plant that is native to North America. Other common names include black snakeroot, bugbane, bugwort, rattleroot, rattletop, rattleweed, and macrotys. Insects avoid it, which accounts for some of these common names.

What are common black cohosh preparations?

Preparations of black cohosh are made from its roots and rhizomes (underground stems). One commercial standardized black cohosh preparation is Remifemin®, which contains black cohosh extract equivalent to 20 mg of root per tablet. The manufacturer changed the formulation of this preparation from a solution (root extracted with ethanol, 60% by volume) to tablets (root extracted with isopropyl alcohol, 40% by volume), complicating the comparison of research results. Other preparations of black cohosh have been less well studied than Remifemin.

Extracts of black cohosh are standardized to 26-deoxyactein content (erroneously reported in the scientific literature as 27-deoxyactein [2]), a member of a group of chemicals known as saponins. Commercially available preparations of black cohosh usually contain 1 mg of total triterpene saponins (expressed as 26-deoxyactein) in each 20-mg dose of extract.

What are the historical uses of black cohosh?

Black cohosh was used in North American Indian medicine for malaise, gynecological disorders, kidney disorders, malaria, rheumatism, and sore throat [3]. It was also used for colds, cough, constipation, hives, and backache and to induce lactation [4]. In 19th-century America, black cohosh was a home remedy used for rheumatism and fever, as a diuretic, and to bring on menstruation. It was extremely popular among a group of alternative practitioners who called black cohosh "macrotys" and prescribed it for rheumatism, lung conditions, neurological conditions, and conditions that affected women's reproductive organs (including menstrual problems, inflammation of the uterus or ovaries, infertility, threatened miscarriage, and relief of labour pains) [4].

What clinical studies have been done on black cohosh and its effect on menopausal symptoms?

Black cohosh is used primarily for hot flashes and other menopausal symptoms. A number of studies using various designs have been conducted to determine whether black cohosh affects menopausal symptoms. Few studies were placebo controlled, and most assessed symptoms by using the Kupperman index-a scale that combines measures of hot flashes, insomnia, and depression but not vaginal dryness. Those with the best study designs are described below.

A randomized, double-blind, placebo-controlled trial was done in breast cancer survivors because most of these women experience hot flashes and many use complementary or alternative remedies. The women were over age 18 and had completed breast cancer treatment at least 2 months before the trial; 85 women (69 of whom completed the trial) took one tablet of placebo or 40 mg/day of black cohosh (as 20 mg twice daily) for 2 months to determine the effect on hot flashes, excessive sweating, palpitations, headaches, poor sleep, depression, and irritability [J.S. Jacobson, Columbia University, written communication, 2002]. Fifty-nine subjects were using tamoxifen (an antiestrogen treatment for breast cancer); tamoxifen users were distributed almost equally between the treatment and control groups. The frequency and intensity of hot flashes decreased in both groups, with no statistical difference between the groups; excessive sweating decreased significantly more in the treatment group than the placebo group. Other symptoms improved equally in both groups, and scores on a health and well-being scale did not change significantly in either group.

A 24-week study in 60 women who had undergone hysterectomy but retained at least one ovary compared the effects of 8 mg/day of a black cohosh extract (as four 2-mg tablets daily; isopropanol extract version of Remifemin) with three oestrogen regimens: estriol (1 mg/day), conjugated estrogens (1.25 mg/day), and oestrogen-progestin therapy (one daily Trisequens® tablet containing 2 mg estradiol and 1 mg norethisterone acetate). In all groups a modified Kupperman index measuring additional physical symptoms was significantly lower 4, 8, 12, and 24 weeks after treatment began. Black cohosh decreased symptoms similarly to the other treatments, but this study was not placebo controlled.

A randomized, double-blind, placebo-controlled trial in 80 menopausal women compared 8 mg/day of a black cohosh extract (as two 2-mg tablets of Remifemin twice daily) with placebo or conjugated estrogens (0.625 mg/day). At 12 weeks, scores on the Kupperman index and the Hamilton anxiety scale were significantly lower in the treated groups than in the placebo group; the scores of participants using black cohosh were somewhat better than the scores of those receiving the oestrogen treatment. This is one of the few studies in which hot flashes were scored separately from other symptoms. Daily hot flashes decreased from 4.9 to 0.7 in the black cohosh group, 5.2 to 3.2 in the oestrogen group, and 5.1 to 3.1 in the placebo group.

A randomized, 12-week study of 55 menopausal women compared an ethanolic extract of black cohosh (40 drops twice daily) with conjugated estrogens (0.6 mg/day) or diazepam (2 mg/day). Regardless of the treatment, all symptoms improved as measured by the Kupperman index, a depression scale, and an anxiety scale. However, this was not a blinded, placebo-controlled trial and diazepam is not a usual treatment for menopausal symptoms.

Although some study results suggest that black cohosh may help relieve menopausal symptoms, other study results do not. Studies of black cohosh have yielded conflicting data, in part because of lack of rigor in study design and short study duration (6 months or less). In addition, interpretation of these studies is complicated by the fact that different amounts of black cohosh from different sources were used in the various studies and their outcome measures were different. To provide more definitive evidence on the effects of black cohosh on menopausal symptoms, NCCAM is funding a 12-month, randomized, placebo-controlled study to determine whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes. The study will also assess whether black cohosh reduces the frequency of other menopausal symptoms and improves quality of life. The study will examine the possible mechanisms of action of black cohosh.

How does black cohosh work?

How black cohosh works is not known. The possibility that black cohosh exhibits estrogenic activity has been studied but the evidence is contradictory.

A compound recently identified in black cohosh-fukinolic acid-was shown to have estrogenic activity in vitro [10]. Other active compounds appear to include triterpene glycosides (including actein and cimicifugoside), resins (including cimicifugin), and caffeic and isoferulic acids.

Effect on hormone levels

Women who have reached menopause generally have lower levels of oestrogen and higher levels of two other hormones-luteinizing hormone (LH) and follicle-stimulating hormone (FSH)-than do women who menstruate. Three of four studies show that black cohosh does not affect LH or FSH.

Effect on the vagina

Because of the marked changes in hormone levels in women who have achieved menopause, numerous modifications occur in the structure and activity of vaginal and uterine tissues. Microscopically, vaginal cells look different after menopause because of decreased oestrogen. Studies have been mixed on whether black cohosh affects vaginal epithelium. One placebo-controlled, double-blind trial of black cohosh showed estrogenic changes in vaginal epithelium of menopausal women, but another study of two Remifemin doses (39 or 127.3 mg/day) found that 6 months of treatment in perimenopausal and menopausal women caused no changes in vaginal cytology.

Effect on the uterus

Menopause is associated with a thinning of the uterine lining (the endometrium). No human studies have adequately evaluated the effect of black cohosh on uterine endometrium.

When uterine weight of immature female mice and growth of ER-positive breast cancer cells (MCF-7) were used to measure the estrogenic effect of black cohosh, black cohosh caused an increase in uterine weight and growth of cancer cells in culture, which the authors said reflected an estrogenic effect. Black cohosh did not exhibit estrogenic effects in a study that measured uterine weight in immature mice and vaginal cell cornification (conversion of cells from columnar to squamous) in ovariectomized rats.

Can black cohosh be harmful?

Black cohosh can cause stomach discomfort and headaches. Clinical trials comparing estrogens with black cohosh preparations have shown a low incidence of adverse effects associated with black cohosh; headaches, gastric complaints, heaviness in the legs, and weight problems were the main adverse effects noted.

A published case of acute hepatitis involved a 47-year-old woman who used black cohosh for symptoms of menopause. She received a liver transplant three weeks after she started taking the herb. The report indicated the dose of black cohosh did not exceed the dosage recommended on the package; but no other dosage information was provided. No other cause for liver disease was found.

Black cohosh usually has not been used for long periods, and published studies have followed women for only 6 months or less. Recently, a large study that followed postmenopausal women taking combined oestrogen and progestin for an average of 5.2 years showed a small but significant increase in the risk of certain diseases, demonstrating the importance of long-term studies in revealing risks that may not be apparent in shorter studies [24]. If black cohosh is estrogenic, long-term use may adversely affect uterine or breast tissue. No studies have been published on long-term safety in humans, particularly regarding abnormal stimulation of cells in the endometrium or breast.

There is a case report of neurological complications in a postterm baby after labour induction with a mixture of black cohosh and blue cohosh (Caullophylum thalictroides) during a home birth.

Other cases of adverse outcomes experienced by neonates born to women who reportedly used blue cohosh to induce labour have been published in peer-review journals.

Who should not take black cohosh?

  • The use of black cohosh during pregnancy has not been rigorously studied. Thus, it would be prudent for pregnant women not to take black cohosh unless they do so under the supervision of their health care provider.
  • Women with breast cancer may want to avoid black cohosh until its effects on breast tissue are understood.

Does black cohosh interact with any drugs or laboratory tests?

Although black cohosh has not been reported to interact with any drugs or to influence laboratory tests, this has not been rigorously studied.

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